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Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031716
Recruitment Status : Enrolling by invitation
First Posted : July 24, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Excavatum, Pectus Scoliosis Idiopathic Behavioral: Meditation Not Applicable

Detailed Description:
This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). We will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. This study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. Research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. Integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. Actigraphy devices will be provided to all participants, and MUSETM to those in the randomized meditation group. The pain team, in accordance with the Pectus Pain Management Protocol, will direct perioperative pain management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants will receive standard perioperative care, anesthetic management, and postoperative pain management per institutional standardized practices. Participants will be randomized into either the Meditation or Control Groups, as deemed appropriate.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
No Intervention: Control
Participants in the control group will receive present standard of care, which includes an assessment of participant/family needs by integrative care after surgery, as well as standard holistic health care by a licensed/certified holistic health specialist. They will not receive the MUSETM focused-attention meditation training or intervention protocol.
Experimental: Meditation
Participants randomized to receive focused-attention meditation training will attend a preoperative training session, provided by a licensed/certified Holistic Health Specialist. The content will include an age appropriate explanation of focused-attention meditation, using breath as the focus; set-up and utilization of the MUSETM headband; and experiential practices. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions, and thoughts), provide self-regulation strategies, and promote healthy and adaptive responses to stress.
Behavioral: Meditation
Participants assigned to the Meditation intervention will receive focused attention meditation training preoperatively, and encouraged to meditate for 20 minutes per day before surgery. In the postoperative inpatient period, the participants will be offered standard holistic health care, reinforcement of meditation training, and encouragement to practice at least 20 minutes of guided focused-attention meditation with breath as their focus, utilizing the MUSETM headband for bio-feedback, every day during their hospital stay. They will be asked to continue using the MUSETM neurofeedback-assisted meditation after hospital discharge, until their visit to repeat pain testing, at which time they will return the MUSETM headband.




Primary Outcome Measures :
  1. Pain score trajectory [ Time Frame: 1 year ]
    Pain scores will be collected preoperatively through 1 year postoperatively

  2. Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.) [ Time Frame: 1 year ]
    Psychosocial measures will be collected preoperatively through 1 year postoperatively

  3. Changes in heart rate variability [ Time Frame: 8 weeks ]
    Heart rate variability will be assessed preoperatively and postoperatively

  4. Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery) [ Time Frame: 8 weeks ]
    Brain activity will be assessed preoperatively and postoperatively

  5. Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks [ Time Frame: 8 weeks ]
    Brain activity will be assessed preoperatively and postoperatively

  6. Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality [ Time Frame: 8 weeks ]
    Sleep efficiency and quality will be assessed preoperatively and postoperatively

  7. Incidence of side-effect measures [ Time Frame: 72 hours postoperatively ]
    Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase


Secondary Outcome Measures :
  1. Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index [ Time Frame: 8 weeks ]
    Quantitative sensory testing will be assessed preoperatively and postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 8 years of age through adulthood
  • Diagnosis of pectus excavatum or adolescent idiopathic scoliosis
  • Scheduled for endoscopic pectus excavatum repair or spine fusion

Exclusion Criteria:

  • History of or active renal or liver disease
  • Major surgery requiring opioids in the last 5 years
  • Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
  • Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
  • History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
  • Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
  • Needing postoperative ventilation or intraoperative cardiac bypass standby
  • BMI >35
  • Pregnant or breastfeeding females
  • Non-English speaking
  • Definite developmental delay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031716


Locations
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United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Vidya Chidambaran, MD Children's Hospital Medical Center, Cincinnati
Publications:
Macrae WA, Davies HTO. Chronic postsurgical pain. In: Crombie IK, editor. Epidemiology of Pain. Seattle: IASP Press, 1999; p. 125-142.
Nakanii M, Nanba T, Uemura S. Pain Caused by the Pectus Bar Implant after the Nuss Procedure for Pectus Excavatum among Junior High and High School Children. Kawasaki Journal of Medical Welfare 2011; 17(1): 15-21.
Uemura S CY. Nuss Procedure for Pectus Excavatum and the Operative Results. Pedia Surg 2003; 35(6): 665-71.
Karydis T, Aguiar F, Foster SL, Mershin A. Performance Characterization of Self-Calibrating Protocols for Wearable EEG Applications. Proceedings of the 8th ACM International Conference on PErvasive Technologies Related to Assistive Environments; 2015; Corfu, Greece: ACM, New York; 2015.
Carver CS, & White, TL. Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: The BIS/BAS scales. Journal of Personality and Social Psychology 1994; 67(2): 319-333.
Chizarifard A. SEM Analysis of Epigenetic Data. Uppsala: Uppsala University; 2014.
Hall M, Frank E, Holmes G, Pfahringer B, Reutemann P, Witten IH. The WEKA data mining software: an update. ACM SIGKDD Explorations Newsletter 2009; 11(1): 10-8.

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04031716    
Other Study ID Numbers: 2017-5817
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with additional internal or external data warehouses/investigators. These include but are not limited to the i2b2-Research Data Warehouse protocol at CCHMC (IRB 2008-0834) for the purpose of linking this data to de-identified copies of the participants' electronic medical records via an i2b2 database. The resulting de-identified i2b2 database will not be part of this research, and will be used to explore secondary phenotypes in future research studies and the NIH-db-GaP (Database of Genotypes and Phenotypes).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Meditation
Pectus Excavatum
Scoliosis
Additional relevant MeSH terms:
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Scoliosis
Funnel Chest
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Developmental
Musculoskeletal Abnormalities
Congenital Abnormalities